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Parents' Guide to Research

Welcome to The Children's Hospital of Philadelphia's Parents' Guide to Medical Research. The purpose of this website is to help individuals interested in taking part in a study gather information about clinical research so that they can decide whether or not to take part.

The website includes information about clinical research, the oversight of clinical research at CHOP and resources from other websites that contain information that may be of interest.

There is a Resources page, which has links materials on other websites including videos, articles and research regulations. The page entitled Is this study right for my child? includes questions and answers related to the decision to take part in a clinical research study. The Clinical Research page explains the research process in more detail. Lastly, if you have questions or would like to speak to someone, there is a page to Contact the IRB, also known as the Institutional Review Board at CHOP. You can use this page to submit questions, concerns or suggestions for improvement to the IRB.

We hope you find information on this site helpful as you think about enrolling your child or yourself in a clinical research study.

Commonly Used Terms in Clinical Research:

Coordinator or Study Coordinator - an individual who assists the investigators by carrying out some of the study operations. The Study Coordinator's duties may include obtaining informed consent, scheduling visits, communicating with the IRB, maintaining the study records, and performing some of the study procedures. The Principal Investigator is responsible for supervising all of the activities performed by the Study Coordinator.

Clinical Research means a study that involves a human subject. Clinical Research differs from regular medical care. In medical care, a patient's doctor can choose the timing and selection of diagnostic tests, procedures, and treatments. In clinical research, the Investigator and Subject don't choose; the care is dictated by the research Protocol. For those interested, there is separate page on this website with more information about Clinical Research.

Intervention means the drug, diet, vaccine, psychological care, or device that is the subject of the research. Participants can be assigned to treatment groups or everyone might get the same treatment depending on the study design.

Investigator or Researcher means an individual conducting a research study. The Principal Investigator is the person responsible for the overall conduct of the study. She may be assisted by one or more co-investigators and Study Coordinators.

IRB or Institutional Review Board - The IRB is the hospital's research ethics committee. The members of the IRB have expertise in scientific areas, the conduct of research, research ethics, federal and state laws that govern research and at CHOP, the issues of importance to understanding children and their development. The IRB is made up of individuals who are independent of the research study. It's job is to protect the rights and welfare of study participants.

Observation means measurements made to follow research participants; the measurements could include things like blood tests, x-Rays, physical exams, and questionnaires. Some studies don't involve any interventions; instead of assigning people to treatment groups, the researchers just see how people with different health conditions do over time. For example, a study could follow lung tests in individuals who smoke cigarettes and those who don't.

Protocol means the detailed description of the research study. This includes the following information:

background explaining why the study should be conducted;

discussion of the design of the study

description of who is allow to take part;

information about study drugs or treatments

detailed list of all of the study visits and the procedures associated with each visit; and

plan for data management, analysis and sample size justification;

safety management plan - adverse events and study monitoring;

discussion of pertinent ethical issues;

key references.

Research - means an Experiment or Study.

Subject or Participant means a person who is taking part in a clinical research study. Participants can be healthy individuals or patients who have with a disease or condition. A patient gets to make their own care choices with the advice and prescription of their doctor; subjects follow the care prescribed in the research protocol.